Prolia Patient Counseling Information

Drug product with same active ingredient: Advise patient that denosumab is also marketed as XGEVA and if taking PROLIA, they should not receive XGEVA.
Hypersensitivity: Advise patient to seek prompt medical attention if signs or symptoms of hypersensitivity reactions occurs. Advise patient who have had signs or symptoms of systemic hypersensitivity reactions that they should not receive denosumab (PROLIA or XGEVA).
Hypocalcaemia: Adequately supplement patients with calcium and vitamin D and instruct them on the importance of maintaining serum calcium levels while receiving PROLIA. Advise patients to seek prompt medical attention if they develop signs or symptoms of hypocalcaemia.
Osteonecrosis of the jaw: Advise patients to maintain good oral hygiene during treatment with PROLIA and to inform their dentist prior to dental procedures that they are receiving PROLIA. Patients should inform their physician or dentist if they experience persistent pain and/or slow healing of the mouth or jaw after dental surgery.
Atypical subtrochanteric and diaphyseal femoral fractures: Advise patients to report new or unusual thigh, hip or groin pain.
Multiple Vertebral Fractures (MVF) following discontinuation of PROLIA treatment: Advise patients not to interrupt PROLIA therapy without talking to their physician.
Serious infections: Advise patients to seek prompt medical attention if they develop signs or symptoms of infections, including cellulitis.
Dermatologic reactions: Advise patients to seek prompt medical attention if they develop signs or symptoms of dermatological reactions (dermatitis, rashes, and eczema).
Musculoskeletal pain: Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking PROLIA. Patients should report severe symptoms if they develop.
Embryo-Fetal toxicity: Pregnancy: Advise patients that PROLIA is contraindicated in women who are pregnant and may cause fetal harm.
Nursing mothers: Advise patients that because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from PROLIA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Schedule of administration: If a dose of PROLIA is missed, administer the injection as soon as convenient. Thereafter, schedule injections every 6 months from the date of the last injection.
INSTRUCTIONS FOR INJECTING WITH THE PROLIA PRE-FILLED SYRINGE WITH A MANUAL NEEDLE GUARD: IMPORTANT: In order to minimize accidental needle sticks, the PROLIA single-use pre-filled syringe will have a green safety guard; manually activate the safety guard after the injection is given.
DO NOT slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection.
Activate the green safety guard (slide over the needle) after the injection.
The grey needle cap on the single-use pre-filled syringe contains dry natural rubber (a derivative of latex); people sensitive to latex should not handle the cap.
Step 1: Remove Grey Needle Cap: Remove needle cap.
Step 2: Administer Subcutaneous Injection: Choose an injection site. The recommended injection sites for PROLIA include: the upper arm OR the upper thigh OR the abdomen.
Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel.
DO NOT put grey needle cap back on needle.
Step 3: Immediately Slide Green Safety Guard Over Needle: With the needle pointing away from you.
Hold the pre-filled syringe by the clear plastic finger grip with one hand. Then, with the other hand, grasp the green safety guard by its base and gently slide it towards the needle until the green safety guard locks securely in place and/or you hear a "click". DO NOT grip the green safety guard too firmly - it will move easily if you hold and slide it gently.
Hold clear finger grip.
Gently slide green safety guard over needle and lock securely in place. Do not grip green safety guard too firmly when sliding over needle.
Immediately dispose of the syringe and needle cap in the nearest sharps container. DO NOT put the needle cap back on the used syringe.